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BIO-GIDE® is recommended for:

• . Simultaneous use of GBR-membrane (BIO-GIDE®) and implants;
• . Augmentation around implants placed in immediate extraction sockets;
• . Augmentation around implants placed in delayed extraction sockets;
• . Localized ridge augmentation for later implantation;
• . Alveolar ridge reconstruction for prosthetic treatment;
• Filling of bone defects after root resection, cystectomy, removal of retained teeth; ●
• . Guided bone regeneration in dehiscence defects; and
• Guided tissue regeneration procedures in periodontal defects,

BIO-GIDE® resorbable bilayer membrane for guided tissue and bone regeneration is physically identical to BIO-GIDE® (K960724), but labeled with an additional indication; guided tissue regeneration in periodontal defects. BIO-GIDE® is a pure collagen membrane obtained by a standardized controlled manufacturing process. The collagen is extracted from veterinary certified pigs and is carefully purified to avoid antigenic reactions. BIO-GIDE® is sterilized in double blisters by gamma irradiation. BIO-GIDE® has a bilayer structure. The porous surface - facing the bone - allows the ingrowth of bone forming cells. The dense surface - facing the soft tissue - prevents the ingrowth of fibrous tissue into the bone defect. The membrane is made of collagen type I and type III without further cross-linking or chemical treatment.

The provided document is a 510(k) summary for the BIO-GIDE® resorbable bilayer membrane, seeking clearance for an additional indication: guided tissue regeneration in periodontal defects. The submission primarily relies on substantial equivalence to predicate devices and literature review rather than a de novo clinical study with specific acceptance criteria and detailed performance metrics of the device itself.

Therefore, the requested information components related to acceptance criteria, specific device performance, sample size for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details are not explicitly available in the provided text related to the BIO-GIDE® device's performance.

The document mainly focuses on comparing the new generation BIO-GIDE® with its predicate devices (previous BIO-GIDE® and BioMend Extend™) for the expanded indication. It cites existing clinical studies from the literature to support the safety and effectiveness of the principle of guided tissue regeneration with collagen membranes, to which the BIO-GIDE® is deemed substantially equivalent.

Here's an attempt to answer based on the available information, noting the missing data:

1. Table of acceptance criteria and the reported device performance

The submission does not define specific quantitative "acceptance criteria" for the BIO-GIDE® device's performance for its new indication in the way one might expect for an AI algorithm or a novel functional device. Instead, the "acceptance" is based on demonstrating substantial equivalence to legally marketed predicate devices for the specified indications. The performance is inferred from the established efficacy of the predicate devices and the cited literature on similar collagen membranes used for guided tissue regeneration.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not applicable in the context of a de novo clinical trial for the BIO-GIDE® device itself. The evidence is derived from a review of previously published clinical studies. Therefore, individual sample sizes would vary across the cited literature, and these studies were not conducted as a test set specifically for this 510(k) submission.
• Data Provenance: The cited studies are peer-reviewed publications. The geographic origin of these studies is not specified in the 510(k) summary but typically would be international. They are clinical studies, hence prospective data collection for their original purposes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The submission relies on scientific literature discussing the clinical outcomes of Guided Tissue Regeneration (GTR) using collagen membranes, not on a ground truth established by experts for a specific test set within this 510(k) submission. Clinical outcomes (e.g., changes in probing depth, attachment levels) assessed by clinicians in the referenced studies would serve as the "ground truth" for those studies.

4. Adjudication method for the test set

Not applicable. This was not a trial involving expert adjudication of device performance in a test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a resorbable membrane for guided tissue/bone regeneration, not an AI or imaging diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm.

7. The type of ground truth used

The "ground truth" is derived from clinical outcomes data reported in the referenced scientific literature regarding the effectiveness of guided tissue regeneration using collagen membranes for periodontal defects. These outcomes typically include measurements like:

• Probing depth reduction
• Clinical attachment level gain
• Bone fill
• Histological evidence of regeneration (in some studies)

8. The sample size for the training set

Not applicable. There is no training set in the context of this device submission. The device is a physical product, not a machine learning model.

9. How the ground truth for the training set was established

Not applicable.

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